Vatech PAX-I User manual

User Manual
Full version
Model : PCH-2500
Version : 2.72
• English
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"i" stands for 'innovation', one of the
core values of VATECH, which aims to
expand accessibility of medical solutions
to more people.
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PaX-i (PCH-2500) User Manual
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Table of Contents
1.
General Information ....................................... 08
1.1
Notice .................................................................................. 08
1.2
Manufacturer's Liability........................................................ 09
1.3
Owner and Operator's Obligations ...................................... 09
1.4
Conventions in this Manual ................................................. 10
2.
Warnings and Precautions............................ 12
2.1
General Safety Precautions................................................. 12
2.2
Electricity-related Safety Precautions.................................. 16
2.3
Radiation Safety .................................................................. 17
2.4
Warnings ............................................................................. 18
3.
PaX-i Imaging System Overview................... 22
3.1
Introduction.......................................................................... 22
 3.1.1 System Components.............................................................22
 3.1.2 Features................................................................................22
 3.1.3 The PaX-i Options.................................................................23
 3.1.4 Standards and Regulations...................................................23
3.2
Imaging System Structure ................................................... 24
3.3
General View of the PaX-i ................................................... 27
 3.3.1 Laser Beams.........................................................................29
 3.3.2 The Exposure Switch............................................................29
 3.3.3 Emergency Stop Button........................................................30
 3.3.4 Components and Positioning Accessories ...........................31
3.4
Examination Programs and Exposure Time........................ 32
 3.4.1 PANO Mode..........................................................................32
 3.4.2 CEPH Mode..........................................................................34
3.5
Marks and Symbols............................................................. 34
 3.5.1 Label Locations.....................................................................36
Table of Contents
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PaX-i (PCH-2500) User Manual
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Table of Contents
4.
Software Overview ......................................... 40
4.1
PC System Requirements (Recommended) ....................... 40
4.2
EasyDent............................................................................. 41
4.3
Imaging Software Overview................................................. 42
 4.3.1 PANO Mode..........................................................................47
 4.3.2 CEPH Mode..........................................................................51
5.
Getting Started ............................................... 54
5.1
Turning on the PaX-i............................................................ 54
5.2
Running the Image Viewer – EasyDent............................... 55
 5.2.1 Creating a New Patient Record ............................................55
 5.2.2 Retrieving Patient Records ...................................................56
5.3
Initiating the Imaging Program............................................. 57
6
Acquiring PANO Images................................ 60
6.1
PANO Imaging Program...................................................... 60
6.2
Setting Exposure Parameters.............................................. 65
6.3
Positioning the Patient......................................................... 68
 6.3.1 Pano Standard Mode............................................................69
 6.3.2 TMJ Open Mode ...................................................................73
 6.3.3 TMJ Close Mode...................................................................76
 6.3.4 Sinus Mode...........................................................................77
6.4
Initiating X-Ray Exposure.................................................... 80
7
Acquiring CEPH Images ................................ 86
7.1
Setting the Exposure Parameters........................................ 86
7.2
Positioning the Patient......................................................... 89
 7.2.1 Lateral Mode.........................................................................90
 7.2.2 Frontal Mode (PA).................................................................92
 7.2.3 SMV Mode ............................................................................94
7.2.4 Waters View Mode................................................................95
 7.2.5 CARPUS Mode.....................................................................96
7.3
Initiating X-Ray Exposure.................................................... 98
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PaX-i (PCH-2500) User Manual
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Table of Contents
8.
Troubleshooting........................................... 102
9.
Cleaning and Maintenance.......................... 104
9.1
Cleaning ............................................................................ 104
9.2
Maintenance...................................................................... 105
10.
Disposing of the Unit ................................... 106
11.
Technical Specications ............................. 110
11.1
Mechanical Specications ................................................. 110
11.2
Technical Specications.................................................... 113
11.3
Electrical Specications..................................................... 117
11.4
Environmental Specications ............................................ 120
1.
Recommended X-Ray Exposure Table ............. 120
2.
X-Ray Dose Data........................................... 122
2.1
DAP Table ......................................................................... 122
2.2
X-ray Leakage Dose.......................................................... 123
2.3
X-Ray Scatter Dose........................................................... 125
3.
Electromagnetic Compatibility (EMC)
Information ................................................... 126
4.
Acquiring image for the pediatric dental
patient............................................................ 130
4.1
Age group: classication table........................................... 130
4.2
Positioning the pediatric dental patient.............................. 130
4.3
Setting exposure values to the age group......................... 131
4.4
The references pertinent to the potential risks for the pediatric
patients.............................................................................. 131
5.
Abbreviations ............................................... 134
Appendices
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General Information
1
1.1
Notice .................................................................................. 08
1.2
Manufacturer's Liability........................................................ 09
1.3
Owner and Operator's Obligations ...................................... 09
1.4
Conventions in this Manual ................................................. 10
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PaX-i (PCH-2500) User Manual
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1. General Information
1.
General Information
 1.1 Notice
Thank you for purchasing the PaX-iTM extra-oral imaging system.
The PaX-iTM is an advanced digital dental diagnostic system that incorporates
a panoramic and Cephalometric (optional) imaging capabilities into a single
system.
This manual describes how to operate the PaX-iTM system. It is recommended
that you thoroughly familiarize yourself with this manual in order to make the
most effective use of this equipment. Observe all cautions, safety messages
and warnings which appear in this manual.
The QR code linked to video le about image capture for the PANO Standard
and CEPH Lateral is provided in the manual. The smartphone and pad which
have the QR code reader application program can be used to watch the video.
Due to a constant technological improvement, the manual may not contain
the most updated information, subjecting to change without prior notice to the
persons concerned. For further information not covered in this manual, please
contact us at:
VATECH Co., Ltd.
Phone: [phone]
E-mail: [email protected]
This document is originally written in English.
The PaX-i is referred to as Equipment in this manual.
Manual Name: PaX-iTM (PCH-2500) User Manual
Version: 2.72
Publication Date: 2018-05
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PaX-i (PCH-2500) User Manual
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1. General Information
 1.2 Manufacturer's Liability
The manufacturers and/or retailers of this equipment assume responsibility for
the safe and normal operation of this product
only when:
■The equipment has been installed by a VATECH authorized technician.
■The equipment has been installed in accordance with all of the cautions and
conditions for installation.
■Genuine VATECH approved equipment and components have been used
at all times.
■All maintenance and repairs have been performed by a VATECH authorized
agent.
■The equipment has been used normally in accordance with the user's
manual.
■The equipment damage or malfunction is not the result of an error on the
part of the owner or operator.
 1.3 Owner and Operator's Obligations
■The owner of this equipment shall perform constancy tests at regular intervals in
order to ensure patient and operator safety. These tests must be performed in
accordance with local X-Ray safety regulations.
■The owner of this equipment shall perform regular inspection and maintenance of
the mechanical and electrical components in this equipment to ensure safe and
consistent operation (IEC 60601-1).
■The owner of this equipment shall ensure inspection and cleaning works are
performed in accordance with the maintenance schedule outlined in Chapter 9:
Cleaning and Maintenance.
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PaX-i (PCH-2500) User Manual
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1. General Information
 1.4 Conventions in this Manual
The following symbols are used throughout this manual. Make sure that you
fully understand each symbol and follow the instructions which accompany it.
To prevent personal injury and/or damage to the equipment, please observe all
warnings and safety information included in this document.
WARNING
WARNING
Indicates information that should be followed
with the utmost care. Failure to comply with a
warning may result in severe damage to the
equipment or physical injury to the operator
and/or patient.
CAUTION
CAUTION
Indicates a situation that demands prompt
and careful action, a specific remedy, or
emergency attention.
X-RAY
X-RAY Indicates a possible danger of exposure to
radiation.
IMPORTANT
IMPORTANT
Indicates a situation or action that could
potentially cause problems to the equipment
and/or its operation.
NOTE
NOTE Emphasizes important information or provide
useful tips and hints.
SINGLE USE Indicates a component which must be replaced
for each new patient.
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Warnings and Precautions
2
2.1
General Safety Precautions................................................. 12
2.2
Electricity-related Safety Precautions.................................. 16
2.3
Radiation Safety .................................................................. 17
2.4
Warnings ............................................................................. 18
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PaX-i (PCH-2500) User Manual
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2. Warnings and Precautions
2.
Warnings and Precautions
WARNING
Be sure to strictly observe all warnings and safety
instructions included in this manual.
 2.1 General Safety Precautions
Operator qualications
This equipment may only be operated by personnel fully trained in its operation.
■To operate this equipment, all operators must:
-have read and understood the user's manual
-be familiar with the fundamental structure and functions of this equipment
-be able to recognize irregularities in the operation of this equipment and
implement appropriate measures to remedy such irregularities.
General safety precautions
■Follow the instructions specied in this manual to ensure the safety of both
the patient and the operator.
■The operator must maintain visual contact with the patient at all times during
imaging.
■Do not open or remove the cover panels on this equipment. Always have
a trained and authorized service technician to carry out inspection and
maintenance of this equipment.
■Do not place foreign objects on this equipment at any time.
■Do not place any objects within this equipment's eld of operation.
■Do not push or pull the equipment. If equipment overbalances, resulting in
the risk of physical injuries or property damage.
■Operators must ask the patient to remain still until the equipment arm has
stopped moving and the reset motion is complete.
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PaX-i (PCH-2500) User Manual
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2. Warnings and Precautions
■Observe all local re regulations. Always keep a re extinguisher near the
equipment.
■The operator of this equipment must be familiar with this equipment's
emergency protocols.
■Ensure that this equipment is kept away from water, moisture, or foreign
substances at all times.
■If this product is exposed to water, moisture, or a foreign substance,
immediately turn off all power to the equipment and contact your VATECH
technical support representative.
■Immediately cease all operation of this equipment if there are signs of oil
leakage and contact you VATECH technical support representative.
Ventilation
■Do not obstruct the equipment's ventilation for air opening. Improper
ventilation could result in the equipment overheating due to a lack of air
circulation.
■Do not spray any type of liquid or aerosol on this equipment as this
may penetrate the system and damage the electrical and mechanical
components inside.
■Always leave a sufcient amount of space around the PC to allow for proper
ventilation.
Hygiene
CAUTION
Always disconnect the equipment from the power outlet
when disinfecting the surfaces of the equipment.
■All removable patient support components (bite block, chin support, temple
supports) can be cleaned using alcohol-based cleaning solutions.
■Patient support handles can be cleaned using alcohol-based cleaning
solutions.
■Other surfaces of the equipment, including the Touchscreen, can be
cleaned using a soft cloth dampened with a mild cleaning solution.
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PaX-i (PCH-2500) User Manual
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2. Warnings and Precautions
■Disinfect the components (bite block, temple supports etc.) of the equipment
that come into contact with the patient or the operator after each exposure.
■New hygiene cover must be provided for each new patient to prevent the
transmission of communicable disease.
IMPORTANT
Do not use aerosol or spray cleaning agents directly on the
surface of the equipment.
Condensation
■Extreme fluctuations in temperature may cause condensation to develop
inside the equipment. Do not turn on the equipment until it has reached
room temperature.
Cooling
■Allow the proper amount of cool down time (for the X-Ray tube to cool
down) to elapse between each image acquisition.
-Mode of operation: Continuous operation with intermittent loading.
-Exposure time: Max. 20.2 s / Resting time: 5 min.
-Column operation time: 1 min / Resting time: 9 min
■If the temperature inside the tube head reaches 60 °C, X-Ray exposure will
cease and an error message will be displayed. Normal X-Ray capabilities
will resume after the generator reaches 58 °C (136.4 ℉).
■If the fan (optional) is installed, it operates automatically when the
temperature surrounding the tube head reaches the pre-dened level: 40 ℃
(104 ℉). The setpoint temperature is congurable.
Turning the equipment on / adjusting the height of the equipment
■Do not position the patient in the equipment while it is initiating as the
patient could be injured if the equipment malfunctions.
■Ensure that the patient is kept clear of the mechanism while adjusting the
height of the equipment.
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PaX-i (PCH-2500) User Manual
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2. Warnings and Precautions
Emergency stop
■If a problem occurs during image acquisition, press the red emergency
stop button to immediately stop all moving parts and cut off all power to the
equipment.
Trouble-free operation
■Never use this equipment in an environment that is susceptible to explosion.
■Always operate the equipment within a temperature range of 10 °C to 35 °C
(50 ℉to 95 ℉) for the safe operation. Image quality may deteriorate if the
equipment is operated outside of this range.
■ Always allow the equipment sufcient time to warm up (while switched on) if
it has been exposed to temperatures of below 10 °C (50 ℉).
■Only perform X-rays of patients if the system is in full working order.
■Always ensure that equipment movement is not obstructed by the patient’s
clothing, a medical device (such as a wheelchair), or the patient themselves.
■Do not leave the patient unattended around the equipment.
■Remove all radio-controlled devices, mobile phones, etc. from the X-Ray
room prior to image acquisition as these objects may cause the equipment
to malfunction.
Modifying the equipment
■Modifying the equipment in any way which may affect the safety of the
operator, patient or other persons is prohibited by law.
■No part of this equipment is serviceable by the user. All maintenance
and repair of this equipment must be performed by a qualified service
technician.
■This product may only be operated with original VATECH accessories or
third-party accessories expressly approved by VATECH.
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PaX-i (PCH-2500) User Manual
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2. Warnings and Precautions
 2.2 Electricity-related Safety Precautions
■Check the status of the power source, PC and cables prior to operating the
equipment.
■Ensure that the on/off switch is set to off when the equipment is not in use.
■Always disconnect the power supply before cleaning the equipment.
■Always keep electrical cords away from hot appliances or radiators.
■DO NOT place the PC or peripheral equipment connected to the PC in the
immediate vicinity of the patient.
■The equipment and PC should be connected to a common protective earth.
■Never overload the equipment’s circuit by sharing it with too many
appliances.
■Use the same power circuit for the PC and the equipment.
Combining this equipment with other devices
■Do not connect this equipment to devices which are not part of the system.
■Do not connect this equipment to a Multiple Portable Socket-Outlet (MPSO)
or extension cord.
Electromagnetic compatibility
■The PaX-i X-Ray unit complies with IEC standard 60601-1-2.
■Medical electrical equipment is subject to special EMC preventive
measures. It must be installed and operated as specied in the Installation
Requirements document.
■If high-voltage systems, radio link systems or MRI systems are located
within 5 m of the unit, please observe the specifications stated in the
installation requirements.
■Portable and mobile RF communications equipment may interfere with
medical electrical equipment. Therefore, the use of mobile wireless phones
in medical ofces or hospital environments must be prohibited.
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PaX-i (PCH-2500) User Manual
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2. Warnings and Precautions
For more details, refer to the document Electromagnetic Compatibility
Information.
Electro-Static Discharge
Connector pins or sockets bearing ESD warning labels must not be touched or
interconnected without observing ESD protective measures.
 2.3 Radiation Safety
WARNING
Since rules and regulations concerning radiation safety
differ between countries, it is the responsibility of the
owner and/or operator of this equipment to comply with
all applicable rules and regulations concerning radiation
safety and protection in their area.
■The operator must remain outside a shielded room during X-Ray exposure
in order to protect himself/herself from radiation.
■The patient must wear a lead apron with neck and thyroid protection during
X-Ray exposure.
■Children and pregnant women must consult with a doctor before X-Ray
exposure.
■This equipment must be housed inside an X-Ray shielded room.
■During imaging; the operator must maintain visual contact with the patient
from outside the shielded area.
■The operator should continuously check the status of the patient and the
equipment during imaging.
■The operator must immediately stop imaging if the equipment malfunctions.
WARNING
As a manufacturer of radiology equipment that conforms
to stringent protection standards around the world, we
guarantee the maximum degree of protection against
radiation hazards for our equipment.
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PaX-i (PCH-2500) User Manual
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2. Warnings and Precautions
 2.4 Warnings
The following warning statements should be obeyed with the utmost care.
Failure to follow these warnings may cause severe damage to the equipment or
physical injuries to the patient and/or operator.
WARNING
X-Ray equipment is hazardous to patient and the operator
if proper exposure safety measures and/or operating
instructions are not observed.
It is important to read this user manual carefully and
strictly abide by all warnings and cautions stated within it.
WARNING
-PaX-i system, like other medical equipment, uses
high-frequency electrical signals that can interfere
with implantable devices such as pacemakers and
implantable cardioverter-defibrillators(ICDs). If the
patient has such an implantable device, you should
be aware of any interference in its operation and
immediately power off the Dental X-ray system.
-PaX-i system is designed to withstand the effects of
defibrillation. However, when possible, disconnect
the Dental X-ray systems during defibrillation since a
malfunction of the safety controls could otherwise result
in electrical burns for the patient.
Lasers
■The system incorporates Class 1 laser products. The light localizers used
in this product are intended for correct patient positioning and must not be
used for any other purpose.
■For maximum safety, advise the patient not to look directly at the laser
beam.
■While adjusting the patient, ensure that the laser beam is not directed at the
patient’s eyes.
■Equipment to liquids may cause an electrical shock or otherwise damage
the system.
■Do not use spray cleaners on this equipment, as this could cause a re.
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PaX-i (PCH-2500) User Manual
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2. Warnings and Precautions
CAUTION
Risk of eye injury!
Do not use this equipment with any other laser sources
and do not make any changes to the settings or processes
that are described in these operating instructions.
Cleaning
■Never expose this equipment to liquids, mists or sprays. Exposing this
equipment to liquids may cause an electrical shock or otherwise damage
the system.
■Do not use spray cleaners on this equipment, as this could cause a re.
During Operation
■Never use this equipment in an environment that is susceptible to explosion.
■Do not place ammable materials near this equipment.
■Do not operate the PC or Touchscreen while the equipment is performing
an operation. Failure to comply with this instruction may result in system
malfunction.
■Immediately stop imaging if the equipment malfunctions in any way.
■If a problem occurs during imaging, press the red emergency stop button
located on top of the handle frame to immediately stop all moving parts and
cut off all power to the equipment’s electrical components.
■Never touch the patient while also touching the SIP/SOP connectors.
In case of an electrical re
■Use only re extinguishers designed for electrical res to extinguish res on
this equipment. Liquid extinguishers, such as those which use water, could
damage the equipment and/or cause injury.
■Unplug the equipment’s power cable before extinguishing any re.
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Installation
■In order to avoid improperly balanced equipment, install the device on a at
surface to maintain stability.
■If the equipment is not stable, property damage and/or personal injury may
occur.
■Do not push or pull the equipment.
■Equipment should only be installed by an authorized technician, complying
with proper installation procedures.
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